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510(k) Data Aggregation

    K Number
    K051331
    Device Name
    19-INCH (48 CM) COLOR LCD MONITOR CDL1902A
    Manufacturer
    TOTOKU ELECTRIC CO., LTD
    Date Cleared
    2005-06-27

    (35 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K030272
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    19-inch (48cm) Color LCD Monitor CDL1902A (CCL192 plus) is to be used in conjunction with the picture archiving communication system (PACS) for medical imaging applications. It is not meant to be used for digital mammography.

    Device Description

    CDL1902A (CCL192 plus) is a 19-inch Color LCD Monitor that has a multi-scanning function corresponding to resolution from VGA 640 x 400 to SXGA 1280 x 1024. This is also compliant with VESA standard display mode.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria, device performance, or any studies proving device performance. The document is a 510(k) summary for a medical monitor, primarily focusing on its substantial equivalence to a predicate device and its intended use. It describes the device, clarifies its classification, and lists the contact information for the submitter. There is no mention of any clinical or performance studies, sample sizes, expert involvement, or ground truth establishment.

    Therefore, I cannot provide the requested information.

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